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  1. Engaging with best editorial and publication practice Shreeya Nanda Deputy Editor

  2. Aims • Understand the origin of and rationale behind our editorial policies • Have aworking knowledge of the policies and know where to find them • Discuss tricky cases and brainstorm potential solutions

  3. Reporting of RCTs remains sub-optimal, but journal endorsement of the CONSORT Statement beneficially influences the reporting of trials Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. Turner L, Shamseer L, Altman DG, Weeks L, Peters J, Kober T, Dias S, Schulz KF, Plint AC, Moher D. Cochrane Database Syst Rev.11, MR000030 (2012). • Articles lacking explicit statements of research ethics board approval and informed consent are infrequent, but continue to be published Failure to report and provide commentary on research ethics board approval and informed consent in medical journals. Finlay KA & Fernandez CV. J Med Ethics. 34(10), 761-764 (2008).

  4. Standards of reporting http://www.equator-network.org/index.aspx?o=1032

  5. Trial registration • All clinical trials must be registered with a suitable publicly accessible registry • e.g. ISRCTN, ClinicalTrials.gov • Why? • Avoids duplication of effort • Makes the process transparent • When? • Before the first participant is recruited

  6. Ethics

  7. Research involving human subjects, material or data • Must comply with the Declaration of Helsinki • Manuscripts should include a statement on the ethical aspects of the study • If ethics approval was needed, committee name and reference number should be included

  8. What if a study is conducted in a country/institution that does not have an ethics committee?

  9. Case 1 • A study on sexual relationships among men who have sex with men conducted in an Asian country by authors affiliated with a European institution is submitted to a journal. • The study has been reviewed by the IRB at the European institution, but not by an appropriate ethics committee in Asia. • How should the Editor proceed?

  10. What if a study has ethics approval, but despite this an Editor has concerns?

  11. Case 2 • A manuscript describing the effects of an invasive intervention for a childhood condition where the pathophysiology is still not fully understood is submitted to a journal. • Approval from an ethics committee is documented in the manuscript. • However, the Editor has concerns regarding the use of such a technique in children. • How should the Editor proceed?

  12. Research involving animals • When is ethics review and/or compliance with guidelines required? • Experimental research on vertebrates or any regulated invertebrates* • Studies involving client-owned animals • Field studies *Octopus vulgarisfrom the stage of its development when it becomes capable of independent feeding

  13. Consent

  14. Consent to participate • All participants must give informed consent • If participants are children, parents or guardians must consent • Exceptions • Questionnaire/survey-based studies • Retrospective studies involving patients’ medical records or archived samples • Ethics committee has waived the need

  15. Consent to publish • Why? • Participants’ right to privacy • Obligation to protect confidential data • Required for: • Identifiable patient information (such as age, gender, clinical data) • Patient images (including scans)

  16. Case 3 • A manuscript describing a novel syndrome is submitted to a journal. • The referees say that the presentation of the clinical phenotype in the pictures provided is not good enough to distinguish it from previously described syndromes and ask for pictures of the patients without eye bars. • How should the Editor proceed?

  17. Resources • BioMed Central’s Editorial Policies (http://www.biomedcentral.com/about/editorialpolicies) • Committee on Publication Ethics (http://publicationethics.org/resources/guidelines) • International Committee of Medical Journal Editors (http://www.icmje.org/) • World Association of Medical Editors (http://www.wame.org/) • Declaration of Helsinki (http://www.wma.net/en/30publications/10policies/b3/) • National Research Ethics Service, UK (http://www.nres.nhs.uk/) • Nuffield Council on Bioethics (http://www.nuffieldbioethics.org/) • Introduction to Reporting Guidelines (EQUATOR Network) (http://www.equator-network.org/index.aspx?o=1032) • ARRIVE guidelines (http://www.nc3rs.org.uk/page.asp?id=1357) • BioMed Central’s Biology and Medical Editors (http://www.biomedcentral.com/authors/biomededitors)

  18. Any questions? Shreeya Nanda Deputy Editor, BioMed Central shreeya.nanda@biomedcentral.com